Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06184698

Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer

Led by Hebei Medical University Fourth Hospital · Updated on 2024-10-09

173

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multi-center, single-arm study to investigate the efficacy and safety of liposomal irinotecan+5-FU/LV+ bevacizumab as second-line therapy in metastatic colorectal cancer in Chinese population.

CONDITIONS

Official Title

Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old
  • Confirmed colon or rectum adenocarcinoma by histology or cytology
  • Metastatic colorectal cancer confirmed as unresectable by radiological examination
  • At least one measurable lesion by RECIST v1.1 criteria
  • Prior first-line treatment with oxaliplatin-based therapy
  • ECOG performance status of 0 to 2
  • Expected survival time of at least 3 months
  • Adequate blood counts: ANC 651.5 x 10^9/L, platelets 65100 x 10^9/L, hemoglobin 6590 g/L, WBC 653.0 x 10^9/L
  • Adequate liver function: total bilirubin 651.5 x ULN, AST, ALP, ALT 652.5 x ULN (or 655 x ULN if liver metastases present)
  • Adequate kidney function: serum creatinine 651.5 x ULN or creatinine clearance 6560 mL/min, proteinuria less than 2+
  • Normal coagulation function (INR 651.5)
  • Willing and able to comply with the study plan and provide written informed consent
Not Eligible

You will not qualify if you...

  • Other malignancy within 5 years except cured in-situ carcinoma or basal cell carcinoma
  • Previous treatment with irinotecan or liposomal irinotecan
  • Microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) status
  • Massive pleural effusion or ascites requiring intervention
  • Active uncontrolled infections requiring systemic treatment
  • Active HIV, HBV, or HCV infection
  • Uncontrolled systemic diseases
  • Severe gastrointestinal disease including active bleeding, grade >1 obstruction, grade >1 diarrhea, or perforation
  • Surgery within 28 days before enrollment (laparotomy, thoracotomy, intestinal resection)
  • Interstitial pneumonia or pulmonary fibrosis
  • Allergy or intolerance to study drugs or their components
  • Pulmonary hemorrhage/hemoptysis grade 652 within one month prior to enrollment
  • Arterial embolism, severe bleeding, or tendency for thrombosis/bleeding within 6 months
  • Symptomatic central nervous system metastases
  • Serum albumin less than 3 g/dL
  • Use of strong CYP3A, CYP2C8, or UGT1A1 inhibitors or inducers
  • Pregnant or breastfeeding, or refusal to use contraception if of childbearing potential
  • Participation in another clinical trial within 30 days before first dose
  • Recent intravenous antineoplastic therapy within 28 days or oral antineoplastic therapy within 14 days
  • Any other reason the investigator judges the patient unsuitable for the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050000

Actively Recruiting

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Research Team

X

Xuhua Hu, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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